A Peri-intubation Oral Intervention to Reduce Oral Flora and VAP
Primary Purpose
Pneumonia
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Chlorhexidine
Sponsored by
About this trial
This is an interventional treatment trial for Pneumonia focused on measuring ventilator-associated pneumonia, hospital acquired pneumonia
Eligibility Criteria
Inclusion Criteria: trauma victim endotracheal intubation within the past 12 hours mechanical ventilation Exclusion Criteria: diagnosis of pneumonia at the time of intubation previous endotracheal tube placement in the last 48 hours burn injuries
Sites / Locations
- Virginia Commonwealth University School of Nursing
Outcomes
Primary Outcome Measures
Oral microbial flora -- measured by semi-quantitative oral culture
Secondary Outcome Measures
Incidence of ventilator associated pneumonia, measured by the clinical pulmonary infection score (CPIS) and obtained on study admission, 48 and 72 hours after intubation
Full Information
NCT ID
NCT00248300
First Posted
November 1, 2005
Last Updated
November 9, 2015
Sponsor
Virginia Commonwealth University
Collaborators
United States Department of Defense, Uniformed Services University of the Health Sciences, TriService Nursing Research Program
1. Study Identification
Unique Protocol Identification Number
NCT00248300
Brief Title
A Peri-intubation Oral Intervention to Reduce Oral Flora and VAP
Official Title
A Peri-intubation Oral Intervention to Reduce Oral Flora and VAP
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
United States Department of Defense, Uniformed Services University of the Health Sciences, TriService Nursing Research Program
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is determine if a single, early dose of chlorhexidine applied within 12 hours after endotracheal tube insertion will reduce the bacteria in the oral cavity and the incidence of pneumonia in trauma victims.
Detailed Description
Pneumonia is the leading cause of death from nosocomial infections. Intubation and mechanical ventilation greatly increase the risk of ventilator associated pneumonia (VAP) which is highest in trauma, burn, neurosurgical and surgical patients. Oral bacteria have been shown to be responsible for the development of VAP since the endotracheal tube provides a pathway for direct entry of bacteria from the oropharynx to the respiratory tract. Therefore, reducing the number of microorganisms in the mouth reduces the pool of organisms available for translocation to and colonization of the lung. The Tri-Service Oral Health Survey showed that military recruits had inferior oral health when compared to their civilian cohorts. Further, oral hygiene is likely to deteriorate in combat situations, increasing oral microbial flora. Intubation of combat casualties in the future will likely be performed in the field by the EMT-B trained combat medic (91W) under adverse conditions. Therefore, interventions to reduce oral microbial flora with intubation are attractive to reduce the incidence of VAP in combat casualties. This study will test the effect of a single peri-intubation oral intervention on oral microbial flora and the development of VAP in traumatic injury. Two hundred trauma patients requiring endotracheal intubation will be randomly assigned to either the intervention or control group over an 18-month data collection period. Data related to oral microbial flora (measured by semi-quantitative oral culture) and VAP (measured by the clinical pulmonary infection score-CPIS) will be obtained on study admission, at 24 (oral culture data only), 48 and 72 hours after intubation. The exact Wilcoxon two-sample one-sided test will be used to test for difference between groups. CPIS data will be compared using an analysis of covariance model. Covariates such as baseline oral culture category, trauma-injury and severity score (TRISS), illness severity (APACHE III) and frequency and timing of usual oral care will also be included. The findings from this study will be the first report of an empirically based peri-intubation oral intervention to reduce VAP and can be easily applied to the care of traumatic injury in both combat and civilian casualties.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia
Keywords
ventilator-associated pneumonia, hospital acquired pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
156 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Chlorhexidine
Intervention Description
Chlorhexidine, 5 ml swab to the oral cavity within 12 hours of endotracheal tube intubation
Primary Outcome Measure Information:
Title
Oral microbial flora -- measured by semi-quantitative oral culture
Time Frame
At 24, 48 and 72 hours after intubation
Secondary Outcome Measure Information:
Title
Incidence of ventilator associated pneumonia, measured by the clinical pulmonary infection score (CPIS) and obtained on study admission, 48 and 72 hours after intubation
Time Frame
At 48 and 72 hours after intubation.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
trauma victim
endotracheal intubation within the past 12 hours
mechanical ventilation
Exclusion Criteria:
diagnosis of pneumonia at the time of intubation
previous endotracheal tube placement in the last 48 hours
burn injuries
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Jo E Grap, PhD
Organizational Affiliation
Virginia Commonwealth University School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University School of Nursing
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15024373
Citation
Grap MJ, Munro CL, Elswick RK Jr, Sessler CN, Ward KR. Duration of action of a single, early oral application of chlorhexidine on oral microbial flora in mechanically ventilated patients: a pilot study. Heart Lung. 2004 Mar-Apr;33(2):83-91. doi: 10.1016/j.hrtlng.2003.12.004.
Results Reference
background
Links:
URL
http://www.nursing.vcu.edu/people/ahns/MaryJoGrap.htm
Description
Dr. Mary Jo Grap (PI) Virginia Commonwealth University School of Nursing webpage
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A Peri-intubation Oral Intervention to Reduce Oral Flora and VAP
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